Author: Themistoklis K. Giannakopoulos
Publisher: Kluwer Law International B.V.
ISBN: 9041124640
Category : Law
Languages : en
Pages : 246
Book Description
Unfair trading practices such as dumping and the granting of subsidies have long been identified as threats to open markets. Yet despite decades of international trading rules, global markets are still jeopardized by practices which can cause material injury to industries and put employment at risk. The European Union has been a leader in its determination to ensure that its industries are not disadvantaged by such practices, that Community interests are defended, and that fair competition is restored where needed. The basic texts which form the legal basis of anti-dumping and anti-subsidy investigations in the Community entered into force in 1996 and 1997. The procedures developed in these texts, as amended, and in their corresponding regulations, are the subject of this extremely helpful guide. Practitioners who must follow these often complex procedures will find precise guidelines for the substantive determinations that must be made such as calculating the material injury, determining the cause of injury, and applying the Community interest test and then be able to move confidently through every procedural step, including the following: Initial complaintQuestionnairesConfrontation meetings and oral hearingsInvestigations by Commission official;Offer and acceptance /rejection of undetaking;Commenting on the Commission's provisional decisionRequesting review of measures and refunds andJudicial review Throughout the presentation the author describes relevant cases and actual measures taken. Tables of cases and measures as well as a bibliography are included. Business people and their counsel, whether engaged in trade within the EU or between any country and an EU Member State, will benefit enormously from the detailed guidance offered in this incomparable volume. The book will also be invaluable to academics and policymakers as an unclouded analysis of anti-dumping/anti-subsidies procedures under EC law.
A Concise Guide to the EU Anti-dumping/anti-subsidies Procedures
Author: Themistoklis K. Giannakopoulos
Publisher: Kluwer Law International B.V.
ISBN: 9041124640
Category : Law
Languages : en
Pages : 246
Book Description
Unfair trading practices such as dumping and the granting of subsidies have long been identified as threats to open markets. Yet despite decades of international trading rules, global markets are still jeopardized by practices which can cause material injury to industries and put employment at risk. The European Union has been a leader in its determination to ensure that its industries are not disadvantaged by such practices, that Community interests are defended, and that fair competition is restored where needed. The basic texts which form the legal basis of anti-dumping and anti-subsidy investigations in the Community entered into force in 1996 and 1997. The procedures developed in these texts, as amended, and in their corresponding regulations, are the subject of this extremely helpful guide. Practitioners who must follow these often complex procedures will find precise guidelines for the substantive determinations that must be made such as calculating the material injury, determining the cause of injury, and applying the Community interest test and then be able to move confidently through every procedural step, including the following: Initial complaintQuestionnairesConfrontation meetings and oral hearingsInvestigations by Commission official;Offer and acceptance /rejection of undetaking;Commenting on the Commission's provisional decisionRequesting review of measures and refunds andJudicial review Throughout the presentation the author describes relevant cases and actual measures taken. Tables of cases and measures as well as a bibliography are included. Business people and their counsel, whether engaged in trade within the EU or between any country and an EU Member State, will benefit enormously from the detailed guidance offered in this incomparable volume. The book will also be invaluable to academics and policymakers as an unclouded analysis of anti-dumping/anti-subsidies procedures under EC law.
Publisher: Kluwer Law International B.V.
ISBN: 9041124640
Category : Law
Languages : en
Pages : 246
Book Description
Unfair trading practices such as dumping and the granting of subsidies have long been identified as threats to open markets. Yet despite decades of international trading rules, global markets are still jeopardized by practices which can cause material injury to industries and put employment at risk. The European Union has been a leader in its determination to ensure that its industries are not disadvantaged by such practices, that Community interests are defended, and that fair competition is restored where needed. The basic texts which form the legal basis of anti-dumping and anti-subsidy investigations in the Community entered into force in 1996 and 1997. The procedures developed in these texts, as amended, and in their corresponding regulations, are the subject of this extremely helpful guide. Practitioners who must follow these often complex procedures will find precise guidelines for the substantive determinations that must be made such as calculating the material injury, determining the cause of injury, and applying the Community interest test and then be able to move confidently through every procedural step, including the following: Initial complaintQuestionnairesConfrontation meetings and oral hearingsInvestigations by Commission official;Offer and acceptance /rejection of undetaking;Commenting on the Commission's provisional decisionRequesting review of measures and refunds andJudicial review Throughout the presentation the author describes relevant cases and actual measures taken. Tables of cases and measures as well as a bibliography are included. Business people and their counsel, whether engaged in trade within the EU or between any country and an EU Member State, will benefit enormously from the detailed guidance offered in this incomparable volume. The book will also be invaluable to academics and policymakers as an unclouded analysis of anti-dumping/anti-subsidies procedures under EC law.
The Use of Alternative Benchmarks in Anti-Subsidy Law
Author: Sophia Müller
Publisher: Springer
ISBN: 3319776134
Category : Law
Languages : en
Pages : 267
Book Description
In the debate over the treatment of China in trade remedy investigations, this book focuses exclusively on anti-subsidy law. As such, it brings a long neglected and often underestimated area of international trade law to the fore.Exploring the delicate relations between the WTO, the EU and China, it focuses on the current legal framework for the use of alternative benchmarks in anti-subsidy law and analyses the consequences that arise from its practical application in investigations against China. Scrutinizing recent developments in WTO anti-subsidy law, in particular the adoption of country-specific rules in accession protocols, the book reveals the shortcomings of the current approach and argues for fundamental reforms. Accordingly, the book provides academics and practitioners alike with vital insights into the legal evolution and practical application of alternative benchmark methodologies in the context of WTO and EU anti-subsidy law, while also putting forward a critical analysis of the status quo.
Publisher: Springer
ISBN: 3319776134
Category : Law
Languages : en
Pages : 267
Book Description
In the debate over the treatment of China in trade remedy investigations, this book focuses exclusively on anti-subsidy law. As such, it brings a long neglected and often underestimated area of international trade law to the fore.Exploring the delicate relations between the WTO, the EU and China, it focuses on the current legal framework for the use of alternative benchmarks in anti-subsidy law and analyses the consequences that arise from its practical application in investigations against China. Scrutinizing recent developments in WTO anti-subsidy law, in particular the adoption of country-specific rules in accession protocols, the book reveals the shortcomings of the current approach and argues for fundamental reforms. Accordingly, the book provides academics and practitioners alike with vital insights into the legal evolution and practical application of alternative benchmark methodologies in the context of WTO and EU anti-subsidy law, while also putting forward a critical analysis of the status quo.
Safeguarding Companies' Rights in Competition and Anti-dumping/anti-subsidies Proceedings
Author: Themistoklis K. Giannakopoulos
Publisher: Kluwer Law International B.V.
ISBN: 9041134042
Category : Law
Languages : en
Pages : 666
Book Description
Focusing on the rules safeguarding procedural due process in the administrative procedures of the Commission, this fully updated edition of a widely used handbook covers the four principal fields that entail enforcement of substantive competition rules: antitrust, merger, anti-dumping/antisubsidies, and State aid. Among the many practical issues raised are the following: the right of directly involved parties to bring an action before the European Courts in merger, anti-dumping/anti-subsidies, and State-aid cases; the rights of complainants in antitrust cases; the rights and obligations of beneficiaries in State-aid cases; the extent to which the right to confidential communication between lawyer and client in thesecases is recognised by the European Commission and the European Courts; the right to silence to avoid self-incrimination in antitrust cases; the right to respect for confidentiality and the right to be heard during the preliminary factfinding procedure of the Commission; the obligations of an undertaking during the fact-finding procedure of the Commission; the right of access to the Commission's file; the right to a fair hearing of all the parties concerned by the Commission proceedings; and the applicability of Article 6 of the European Convention of Human Rights (ECHR) to EU antitrust procedures. Three tables consolidate briefly and comparatively the rights and the obligations of the private parties in the four proceedings, as well as their right to bring an action before the European Courts. These tables give the reader the opportunity to easily check out what is the situation in the four proceedings regarding a specific right or obligation. The author's analysis draws on all the relevant judgments of the European Courts, and the book comes with a wealth of reference material, including detailed footnotes, lists of legislation and cases in both chronological and alphabetical order, and an extensive bibliography.
Publisher: Kluwer Law International B.V.
ISBN: 9041134042
Category : Law
Languages : en
Pages : 666
Book Description
Focusing on the rules safeguarding procedural due process in the administrative procedures of the Commission, this fully updated edition of a widely used handbook covers the four principal fields that entail enforcement of substantive competition rules: antitrust, merger, anti-dumping/antisubsidies, and State aid. Among the many practical issues raised are the following: the right of directly involved parties to bring an action before the European Courts in merger, anti-dumping/anti-subsidies, and State-aid cases; the rights of complainants in antitrust cases; the rights and obligations of beneficiaries in State-aid cases; the extent to which the right to confidential communication between lawyer and client in thesecases is recognised by the European Commission and the European Courts; the right to silence to avoid self-incrimination in antitrust cases; the right to respect for confidentiality and the right to be heard during the preliminary factfinding procedure of the Commission; the obligations of an undertaking during the fact-finding procedure of the Commission; the right of access to the Commission's file; the right to a fair hearing of all the parties concerned by the Commission proceedings; and the applicability of Article 6 of the European Convention of Human Rights (ECHR) to EU antitrust procedures. Three tables consolidate briefly and comparatively the rights and the obligations of the private parties in the four proceedings, as well as their right to bring an action before the European Courts. These tables give the reader the opportunity to easily check out what is the situation in the four proceedings regarding a specific right or obligation. The author's analysis draws on all the relevant judgments of the European Courts, and the book comes with a wealth of reference material, including detailed footnotes, lists of legislation and cases in both chronological and alphabetical order, and an extensive bibliography.
Commercial Law of the European Union
Author: Gabriël Moens
Publisher: Springer Science & Business Media
ISBN: 9048187745
Category : Law
Languages : en
Pages : 486
Book Description
? The Hon. Michael Kirby AC CMG This splendid book performs the heroic task of introducing readers to the large canvas of the commercial law of the European Union (EU). The EU began as an economic community of six nations but has grown into 27 member states, sharing a signi?cant political, social and legal cohesion and serving almost 500 million citizens. It generates approximately 30% of the nominal gross world product. The EU is a remarkable achievement of trans-national co-operation, given the history (including recent history) of national, racial, ethnic and religious hatred and con?ict preceding its creation. Although, as the book recounts, the institutions of the EU grew directly out of those of the European Economic Community, created in 1957 [1.20], the genesis of the EU can be traced to the sufferings of the Second World War and to the disclosure of the barbarous atrocities of the Holocaust. Out of the chaos and ruins of historical enmities and the shattered cities and peoples that survived those terrible events, arose an astonishing pan- European Movement.
Publisher: Springer Science & Business Media
ISBN: 9048187745
Category : Law
Languages : en
Pages : 486
Book Description
? The Hon. Michael Kirby AC CMG This splendid book performs the heroic task of introducing readers to the large canvas of the commercial law of the European Union (EU). The EU began as an economic community of six nations but has grown into 27 member states, sharing a signi?cant political, social and legal cohesion and serving almost 500 million citizens. It generates approximately 30% of the nominal gross world product. The EU is a remarkable achievement of trans-national co-operation, given the history (including recent history) of national, racial, ethnic and religious hatred and con?ict preceding its creation. Although, as the book recounts, the institutions of the EU grew directly out of those of the European Economic Community, created in 1957 [1.20], the genesis of the EU can be traced to the sufferings of the Second World War and to the disclosure of the barbarous atrocities of the Holocaust. Out of the chaos and ruins of historical enmities and the shattered cities and peoples that survived those terrible events, arose an astonishing pan- European Movement.
Civil Procedure in EU Competition Cases Before the English and Dutch Courts
Author: George Cumming
Publisher: Kluwer Law International B.V.
ISBN: 9041131922
Category : Law
Languages : en
Pages : 426
Book Description
For decades it seemed clear that EC competition law was enforceable effectively at the national level, and ECJ case law has continued to bear this out. In recent years, however, the Commission has been proposing harmonization of national rules of procedure in competition cases, implying that procedural autonomy is insufficient on its own to produce an effective enforcement system in this area. As the authors of this book clearly demonstrate, this suggests a binary system governing the enforcement of EC Articles 81 and 82: namely, that led by the Commission through directives and eventual regulations, and that built on ECJ principles in areas not dealt with by such Community instruments. This book describes and analyzes not only the specific Commission recommendations, but also the manner and extent to which these recommendations are or may be implemented in civil procedure. In particular, the authors consider changes which may be required if these recommendations are incorporated into Dutch and English rules of civil procedure. Also addressed are elements of procedure not mentioned by the Commission but which might usefully be considered in the context of ECJ principles of effectiveness, equivalence and effective judicial protection of rights. At the heart of the study is a detailed analysis of the Commission White Paper on Damages Actions and the Commission Staff Working Paper, both issued early in 2009. The in-depth analysis ranges over procedural aspects of such elements as the following: andstanding; anddisclosure and access to evidence; andburden of proof; andfault/no fau andcosts of damages actions; andinjunctions; andcivil versus administrative enforcement; andlimitations; andleniency programmes; andcollective actions; andconfidentiality; and andforms of compensation. Anticipating as it does a looming impasse in European competition law, this remarkable book sheds defining light on the real implications of EC competition law for parties to damages actions, not only in the national systems studied but for all Member States. For practitioners and jurists it offers a particularly useful approach to the handling of cases involving European competition law, and also serves as a guide to current trends and as a clarification of doctrine.
Publisher: Kluwer Law International B.V.
ISBN: 9041131922
Category : Law
Languages : en
Pages : 426
Book Description
For decades it seemed clear that EC competition law was enforceable effectively at the national level, and ECJ case law has continued to bear this out. In recent years, however, the Commission has been proposing harmonization of national rules of procedure in competition cases, implying that procedural autonomy is insufficient on its own to produce an effective enforcement system in this area. As the authors of this book clearly demonstrate, this suggests a binary system governing the enforcement of EC Articles 81 and 82: namely, that led by the Commission through directives and eventual regulations, and that built on ECJ principles in areas not dealt with by such Community instruments. This book describes and analyzes not only the specific Commission recommendations, but also the manner and extent to which these recommendations are or may be implemented in civil procedure. In particular, the authors consider changes which may be required if these recommendations are incorporated into Dutch and English rules of civil procedure. Also addressed are elements of procedure not mentioned by the Commission but which might usefully be considered in the context of ECJ principles of effectiveness, equivalence and effective judicial protection of rights. At the heart of the study is a detailed analysis of the Commission White Paper on Damages Actions and the Commission Staff Working Paper, both issued early in 2009. The in-depth analysis ranges over procedural aspects of such elements as the following: andstanding; anddisclosure and access to evidence; andburden of proof; andfault/no fau andcosts of damages actions; andinjunctions; andcivil versus administrative enforcement; andlimitations; andleniency programmes; andcollective actions; andconfidentiality; and andforms of compensation. Anticipating as it does a looming impasse in European competition law, this remarkable book sheds defining light on the real implications of EC competition law for parties to damages actions, not only in the national systems studied but for all Member States. For practitioners and jurists it offers a particularly useful approach to the handling of cases involving European competition law, and also serves as a guide to current trends and as a clarification of doctrine.
The Future of Trade Defence Instruments
Author: Marc Bungenberg
Publisher: Springer
ISBN: 3319953060
Category : Law
Languages : en
Pages : 318
Book Description
This EYIEL Special Issue is devoted to the European Union’s Trade Defence Instruments (TDIs). The recent legislative changes at the EU level are indicative of global policy trends and legal challenges surrounding trade remedies law. Although TDI measures have always been a fiercely debated topic in international economic law, they have received increased attention in recent years. This book offers a comprehensive and insightful legal analysis of the recent legislative changes at the EU level and investigates TDIs in the context of regional trade relationships, including the United Kingdom in post-Brexit times. Beyond the EU, it examines the national trade defence law frameworks of important trading partners such as Switzerland, the United States, China and Vietnam.The selected contributions in this edited volume examine the recent trends in trade defence law from a legal and practical perspective and offer analytical insights from EU officials, legal practitioners and leading academics. A unique collection of essays in a changed global framework, this EYIEL Special Issue provides an up-to-date overview of the state of play of trade defence in the EU and around the globe.
Publisher: Springer
ISBN: 3319953060
Category : Law
Languages : en
Pages : 318
Book Description
This EYIEL Special Issue is devoted to the European Union’s Trade Defence Instruments (TDIs). The recent legislative changes at the EU level are indicative of global policy trends and legal challenges surrounding trade remedies law. Although TDI measures have always been a fiercely debated topic in international economic law, they have received increased attention in recent years. This book offers a comprehensive and insightful legal analysis of the recent legislative changes at the EU level and investigates TDIs in the context of regional trade relationships, including the United Kingdom in post-Brexit times. Beyond the EU, it examines the national trade defence law frameworks of important trading partners such as Switzerland, the United States, China and Vietnam.The selected contributions in this edited volume examine the recent trends in trade defence law from a legal and practical perspective and offer analytical insights from EU officials, legal practitioners and leading academics. A unique collection of essays in a changed global framework, this EYIEL Special Issue provides an up-to-date overview of the state of play of trade defence in the EU and around the globe.
The Interplay Between Competition Law and Intellectual Property
Author: Gabriella Muscolo
Publisher: Kluwer Law International B.V.
ISBN: 9041186905
Category : Law
Languages : en
Pages : 633
Book Description
Although competition law and intellectual property are often interwoven, until this book there has been little guidance on how they work together in practice. As the intersection between the two fields continues to grow worldwide, both in case law and in regulation, the book's markets-based approach, focusing on sectors such as pharmaceuticals, IT, telecoms, energy and agriculture in eleven of the world's most active jurisdictions, provides a much-needed in-depth understanding of how this interplay reveals itself among the different legal systems. Written by a range of authors including judges, regulators, academics, economists and practitioners in both fields, the book provides an international comparative perspective as well as detailed analysis of specific cases, policies and proposals for change. Among the issues and topics covered are the following: – free movement of goods and the protection of intellectual property rights; – standard essential patents & injunction in patent cases; – intellectual property rights between technological development and consumer protection; – geo-blocking; – online platforms and antitrust; – excessive prices. In this context, special attention is paid throughout to the increasing dialogue among Competition Authorities and between Judges and Competition Authorities around the world. As matchless remedy for the lack of uniformity heretofore, the book's investigation of the nexus between competition law and intellectual property in different sectors and in various countries takes a giant step towards a more-balanced approach and more-levelled regulation and practices. It will be warmly appreciated by policy makers, decision makers, regulators, practitioners and academics in both competition law and intellectual property fields
Publisher: Kluwer Law International B.V.
ISBN: 9041186905
Category : Law
Languages : en
Pages : 633
Book Description
Although competition law and intellectual property are often interwoven, until this book there has been little guidance on how they work together in practice. As the intersection between the two fields continues to grow worldwide, both in case law and in regulation, the book's markets-based approach, focusing on sectors such as pharmaceuticals, IT, telecoms, energy and agriculture in eleven of the world's most active jurisdictions, provides a much-needed in-depth understanding of how this interplay reveals itself among the different legal systems. Written by a range of authors including judges, regulators, academics, economists and practitioners in both fields, the book provides an international comparative perspective as well as detailed analysis of specific cases, policies and proposals for change. Among the issues and topics covered are the following: – free movement of goods and the protection of intellectual property rights; – standard essential patents & injunction in patent cases; – intellectual property rights between technological development and consumer protection; – geo-blocking; – online platforms and antitrust; – excessive prices. In this context, special attention is paid throughout to the increasing dialogue among Competition Authorities and between Judges and Competition Authorities around the world. As matchless remedy for the lack of uniformity heretofore, the book's investigation of the nexus between competition law and intellectual property in different sectors and in various countries takes a giant step towards a more-balanced approach and more-levelled regulation and practices. It will be warmly appreciated by policy makers, decision makers, regulators, practitioners and academics in both competition law and intellectual property fields
Merger Decisions and the Rules of Procedure of the European Community Courts
Author: George Cumming
Publisher: Kluwer Law International B.V.
ISBN: 904114286X
Category : Law
Languages : en
Pages : 769
Book Description
Article 340 TFEU, which provides a method of compensation for victims of the Commission’s errors, is invoked as the basis for actions against Commission decisions under the Merger Control Regulation. Accordingly, the rules of procedure of the Community Courts come into play. This probing analysis asks the important questions: What limits can be imposed on the discretion of the Community Courts acting within their own rules of procedure? Is the manner in which the Court of Justice interprets those rules sufficient? Focusing on the crucial Court responsibilities of investigating facts and assessing economic damage in relation to the type of non-contractual liability apparent in antitrust cases, the author convincingly demonstrates that the scope for ‘case management’ by the Courts is strictly limited, and may engender information or evidentiary deficits that contravene ECHR Art 6.1 as well as the principles of effective judicial protection and rectitude of decision. A claim for compensation pursuant to Art 340 TFEU may be struck merely because the basic elements of the cause of action cannot be established to a minimal level.
Publisher: Kluwer Law International B.V.
ISBN: 904114286X
Category : Law
Languages : en
Pages : 769
Book Description
Article 340 TFEU, which provides a method of compensation for victims of the Commission’s errors, is invoked as the basis for actions against Commission decisions under the Merger Control Regulation. Accordingly, the rules of procedure of the Community Courts come into play. This probing analysis asks the important questions: What limits can be imposed on the discretion of the Community Courts acting within their own rules of procedure? Is the manner in which the Court of Justice interprets those rules sufficient? Focusing on the crucial Court responsibilities of investigating facts and assessing economic damage in relation to the type of non-contractual liability apparent in antitrust cases, the author convincingly demonstrates that the scope for ‘case management’ by the Courts is strictly limited, and may engender information or evidentiary deficits that contravene ECHR Art 6.1 as well as the principles of effective judicial protection and rectitude of decision. A claim for compensation pursuant to Art 340 TFEU may be struck merely because the basic elements of the cause of action cannot be established to a minimal level.
Sixty Years of EU State Aid Law and Policy
Author: Eugene Stuart
Publisher: Kluwer Law International B.V.
ISBN: 9041189246
Category : Law
Languages : en
Pages : 380
Book Description
If an EU industrial policy can be said to exist, its contours may be found in the complex and evolving concept of State aid. Because approaching any State aid issue can be fraught with multiple and sometimes conflicting interpretations, an in-depth analysis of the rationales, initiatives, and regulations that constitute the State aid system is much needed. In response to this need, this book provides a fine-grained clarifying context through which recent reforms, policy shifts, and judicial decisions concerning State aid can be understood and applied to specific situations. Focusing on the impacts of landmark cases and policy developments leading up to a deeply informed critique of the current State Aid Modernisation Programme, the authors cover such issues and topics as the following: – linkages to other established and evolving EU common policies and common strategies; – effect of EU State aid rules in the expanding geopolitical regions of EU influence; – interaction with the WTO Subsidies and Countervailing Measures Agreement; – the problem of a ‘subsidies culture’; – how the European Commission’s notion of ‘bad’ State aid has evolved; – effect of EU policy imperatives (e.g., environmental goals) which implicitly argue for increased subsidisation; – nexus with EU tax harmonisation; – competition among undertakings versus competition among Member State policies; and – nature of the quasi-devolution of regulatory responsibilities to EU Member States. This book is a crucially important source of both theoretical enlightenment and practical wisdom that will greatly enhance confident progress through any legal matter involving EU State aid rules. It will prove of immeasurable value to practitioners, in-house counsel, policymakers, and academics for many years to come.
Publisher: Kluwer Law International B.V.
ISBN: 9041189246
Category : Law
Languages : en
Pages : 380
Book Description
If an EU industrial policy can be said to exist, its contours may be found in the complex and evolving concept of State aid. Because approaching any State aid issue can be fraught with multiple and sometimes conflicting interpretations, an in-depth analysis of the rationales, initiatives, and regulations that constitute the State aid system is much needed. In response to this need, this book provides a fine-grained clarifying context through which recent reforms, policy shifts, and judicial decisions concerning State aid can be understood and applied to specific situations. Focusing on the impacts of landmark cases and policy developments leading up to a deeply informed critique of the current State Aid Modernisation Programme, the authors cover such issues and topics as the following: – linkages to other established and evolving EU common policies and common strategies; – effect of EU State aid rules in the expanding geopolitical regions of EU influence; – interaction with the WTO Subsidies and Countervailing Measures Agreement; – the problem of a ‘subsidies culture’; – how the European Commission’s notion of ‘bad’ State aid has evolved; – effect of EU policy imperatives (e.g., environmental goals) which implicitly argue for increased subsidisation; – nexus with EU tax harmonisation; – competition among undertakings versus competition among Member State policies; and – nature of the quasi-devolution of regulatory responsibilities to EU Member States. This book is a crucially important source of both theoretical enlightenment and practical wisdom that will greatly enhance confident progress through any legal matter involving EU State aid rules. It will prove of immeasurable value to practitioners, in-house counsel, policymakers, and academics for many years to come.
Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law
Author: Amalia Athanasiadou
Publisher: Kluwer Law International B.V.
ISBN: 9403501146
Category : Law
Languages : en
Pages : 349
Book Description
Reverse payment settlements or “pay-for-delay agreements” between originators and generic drug manufacturers create heated debates regarding the balance between competition and intellectual property law. These settlements touch upon sensitive issues such as timely generic entry and access to affordable pharmaceuticals and also the need to preserve innovation incentives for originators and to strengthen the pipeline of life-saving pharmaceuticals. This book is one of the first to critically and comparatively analyse how such patent settlements and various other strategies employed by the pharmaceutical industry are scrutinised by both United States (US) and European courts and enforcement authorities, and to discuss the applicable legal tests and the main criteria used for their assessment. The book’s ultimate objective is to provide guidance to the pharmaceutical industry regarding the types of patent settlements, strategies and conduct which may be problematic from US antitrust and European Union (EU) competition law perspectives and to assist practitioners in structuring settlements which are both efficient and compliant. To this end, an exhaustive legal analysis of some of the most controversial issues regarding pharmaceutical patent settlements is provided, including: – the lengthy split among US Circuit Courts on the issue of pay-for-delay settlements, its resolution by the US Supreme Court in FTC v. Actavisand subsequent jurisprudence; – the decision of Lundbeck v. Commissionby the European General Court and the Servier decision of the European Commission; – the Roche/Novartisdecision of the European Court of Justice and the most important decisions by National Competition Authorities on pharma patent settlements in the EU; – an overview of other types of strategies such as product-hopping and product reformulations, no-authorised generic commitments, problematic side-deals, mechanisms affecting generic substitution; – the rejection of the “scope of the patent” test in both the US and the EU and the balancing of patent law and antitrust law considerations in the prevailing applicable tests; – the benefits of settlements and the main criteria for assessing their legitimacy under US antitrust and EU competition law. The analysis provides concrete examples of both illegitimate and legitimate settlements and strategies, emphasising on conduct that falls within a grey zone and on the circumstances and criteria under which such conduct could be deemed problematic from an antitrust perspective. This book will serve as a valuable guide for pharmaceutical companies wishing to minimise the risk of engaging in conduct that could potentially infringe US antitrust and EU competition law. It further aims to save courts and enforcement agencies and also practitioners and academics considerable time and resources by providing an exhaustive analysis of the relevant caselaw, with the ultimate goal to increase legal certainty on the most controversial aspects of patent settlements in the pharmaceutical industry.
Publisher: Kluwer Law International B.V.
ISBN: 9403501146
Category : Law
Languages : en
Pages : 349
Book Description
Reverse payment settlements or “pay-for-delay agreements” between originators and generic drug manufacturers create heated debates regarding the balance between competition and intellectual property law. These settlements touch upon sensitive issues such as timely generic entry and access to affordable pharmaceuticals and also the need to preserve innovation incentives for originators and to strengthen the pipeline of life-saving pharmaceuticals. This book is one of the first to critically and comparatively analyse how such patent settlements and various other strategies employed by the pharmaceutical industry are scrutinised by both United States (US) and European courts and enforcement authorities, and to discuss the applicable legal tests and the main criteria used for their assessment. The book’s ultimate objective is to provide guidance to the pharmaceutical industry regarding the types of patent settlements, strategies and conduct which may be problematic from US antitrust and European Union (EU) competition law perspectives and to assist practitioners in structuring settlements which are both efficient and compliant. To this end, an exhaustive legal analysis of some of the most controversial issues regarding pharmaceutical patent settlements is provided, including: – the lengthy split among US Circuit Courts on the issue of pay-for-delay settlements, its resolution by the US Supreme Court in FTC v. Actavisand subsequent jurisprudence; – the decision of Lundbeck v. Commissionby the European General Court and the Servier decision of the European Commission; – the Roche/Novartisdecision of the European Court of Justice and the most important decisions by National Competition Authorities on pharma patent settlements in the EU; – an overview of other types of strategies such as product-hopping and product reformulations, no-authorised generic commitments, problematic side-deals, mechanisms affecting generic substitution; – the rejection of the “scope of the patent” test in both the US and the EU and the balancing of patent law and antitrust law considerations in the prevailing applicable tests; – the benefits of settlements and the main criteria for assessing their legitimacy under US antitrust and EU competition law. The analysis provides concrete examples of both illegitimate and legitimate settlements and strategies, emphasising on conduct that falls within a grey zone and on the circumstances and criteria under which such conduct could be deemed problematic from an antitrust perspective. This book will serve as a valuable guide for pharmaceutical companies wishing to minimise the risk of engaging in conduct that could potentially infringe US antitrust and EU competition law. It further aims to save courts and enforcement agencies and also practitioners and academics considerable time and resources by providing an exhaustive analysis of the relevant caselaw, with the ultimate goal to increase legal certainty on the most controversial aspects of patent settlements in the pharmaceutical industry.